MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: PFNA-II SHORT; ROD, FIXATION, INTRAMEDULLARY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 01/01/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: tan m.W.P., vellasamy a., (2021) clinical outcomes between long and short proximal femoral nail antirotation (pfna-ii) devices in the management of extracapsular hip fractures: a retrospective cohort study, current orthopaedic practice volume 32 _ number 3, pages 1-5 (singapore).This retrospective study aims to compare two specific types of intramedullary nail constructs for intertrochanteric fractures by evaluating the clinical and radiographic outcomes.From january 2015 to december 2016, a total of 115 surgeries were performed on patients who sustained extracapsular hip fractures.Based on our inclusion criteria, a total of 91 patients who had traumatic intertrochanteric fractures (revised ao/ota-31 a1 and a2) of the femur were treated by 61 long and 30 short pfna-ii devices (synthes gmbh, oberdorf, switzerland).Twenty-four patients were excluded because they had other implants for their hip fractures.There were 58 women and 33 men, with the age range of 49 to 99yr (mean: 78.9± 9.8 yr), included in this study.The short pfna-ii devices used were 240mm in length, while the long pfna-ii devices used ranged from 260mm to 340 mm.Patients had follow-up for at least 6mo (range: 6 mo to 2 yr).Complications reported: of the 92 patients, one patient died in the immediate postoperative period.The case was a patient who had a long pfna device inserted, although they died from an unrelated post operative complication of pneumonia.The long pfna-ii group had more complications: one patient who had a periprosthetic femoral shaft fracture after a fall and another patient who suffered a malunion that was treated conservatively.8 urinary tract infection; 8 pneumonia.2 pulmonary embolism; 1 nonunion.The short pfna-ii group had more complications: one patient who had a nonunion that required reoperation with bone grafting.4 urinary tract infection; 1 nonunion.This report is for unk - constructs: pfna-ii.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is for unk - constructs: pfna-ii short.

• Brand Name: UNK - CONSTRUCTS: PFNA-II SHORT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15107874
• MDR Text Key: 296659911
• Report Number: 8030965-2022-05226
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention